FDA Product Code LZA: Polymer Patient Examination Glove
Examination gloves are among the most used medical devices in healthcare settings. FDA product code LZA covers polymer patient examination gloves — including nitrile, vinyl, and other synthetic materials.
These gloves provide a protective barrier between healthcare workers and patients during examination and non-surgical procedures. Nitrile gloves are the preferred choice for latex-sensitive patients and clinicians.
LZA devices are Class I medical devices, regulated under 21 CFR 880.6250 and reviewed by the FDA General Hospital panel.
Leading manufacturers include O&M Halyard, Inc., Medline Industries, Inc. and Shen Wei (Usa), Inc..
1170
Total
1170
Cleared
117d
Avg days
1984
Since
1170 devices
Cleared
Jul 28, 2021
Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors
Shen Wei (Usa), Inc.
General Hospital
79d
Cleared
Jul 23, 2021
Nitrile Patient Examination Gloves
Huayuan Medical Technology(Shangqiu) Co., Ltd.
General Hospital
109d
Cleared
Jul 22, 2021
Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital
90d
Cleared
Jul 21, 2021
Nitrile Patient Examination Glove
Yunnan Huazhiyuan Medical Technology Co., Ltd.
General Hospital
135d
Cleared
Jul 20, 2021
Disposable Nitrile Medical Examination Glove
Jiangsu Cureguard Glove Co., Ltd.
General Hospital
134d
Cleared
Jul 15, 2021
Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
Edma Group, LLC
General Hospital
57d
Cleared
Jul 12, 2021
Nitrile Patient Examination Glove
Jiangxi Zhonghong Pulin Medical Products Co., Ltd.
General Hospital
124d
Cleared
Jul 12, 2021
Nitrile Examination Gloves
5r Med Instruments (Chengdu) Co., Ltd.
General Hospital
119d
Cleared
Jul 10, 2021
Medical Nitrile Examination Gloves (Power free, Blue)
Jiangxi Hongda Medical Equipment Group , Ltd.
General Hospital
134d
Cleared
Jun 28, 2021
Violet Nitrile Powder Free Patient Examination Glove, Non Sterile
Onetexx Sdn Bhd
General Hospital
122d
Cleared
Jun 28, 2021
White Nitrile Powder Free Patient Examination Glove, Non Sterile
Onetexx Sdn Bhd
General Hospital
105d
Cleared
Jun 25, 2021
Nitrile Glove
Jiangsu Dihong Industry and Trade Co., Ltd.
General Hospital
60d
Cleared
Jun 24, 2021
Powder Free Black Nitrile Examination Glove
Vietglove Corporation
General Hospital
391d
Cleared
Jun 21, 2021
Biodegradable Powder Free Neoprene Examination Glove, Low Dermatitis Potential Claim, Green
Shen Wei (Usa), Inc.
General Hospital
329d
Cleared
Jun 21, 2021
Powder Free Blue Nitrile Examination Glove
Duramitt Sdn Bhd
General Hospital
133d
Cleared
Jun 16, 2021
AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange)
Megine Industries Sdn Bhd
General Hospital
47d
Cleared
Jun 13, 2021
Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Green Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Black Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Ansell Healthcare Products, LLC
General Hospital
123d
Cleared
Jun 04, 2021
Nitrile Patient Examination Gloves
Huayuan Medical Technology(Shangqiu) Co., Ltd.
General Hospital
59d
Cleared
May 13, 2021
Powder Free Nitrile Examination Glove
Pastel Glove Sdn Bhd
General Hospital
94d
Cleared
May 07, 2021
Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors)
Central Medicare Sdn Bhd
General Hospital
214d
Cleared
May 07, 2021
Blue Nitrile Powder Free Patient Examination Glove, Non Sterile
Onetexx Sdn Bhd
General Hospital
88d
Cleared
May 07, 2021
Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue)
Meditech Gloves Sdn Bhd
General Hospital
53d
Cleared
Apr 29, 2021
Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue)
Harbour Health, LLC
General Hospital
30d
Cleared
Apr 28, 2021
Disposable Nitrile Examination Gloves
Shandong Zhushi Pharmaceutical Group Co., Ltd.
General Hospital
156d